# Horiba Abx

- Location (FDA's records): Montpellier, FR
- FDA decisions: 37 (2005–2026): 37 510(k) clearances
- Names in FDA's records: Horiba Abx (19); HORIBA ABX SAS (18)
- Product codes: GKZ (7), DCK (3), CFR (3), CGX (2), CJY (2), JIT (2), JFY (2), CJE (2), CDQ (1), CIG (1), JIX (1), JFJ (1)
- 510(k) review time since 2016: median 244 days, against 254 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 95 (20 its own); citations of its devices by later devices: 35 (20 its own)
- Recalls linked to its devices: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostic Systems, Inc.: 19 (https://510kreport.com/company/roche-diagnostic-systems)
- Abx Diagnostics: 8 (https://510kreport.com/company/abx-diagnostics)
- Olympus America, Inc.: 7 (https://510kreport.com/company/olympus-america)
- Trace America, Inc.: 4 (https://510kreport.com/company/trace-america)
- Roche Analytical Instruments, Inc.: 4 (https://510kreport.com/company/roche-analytical-instruments)
- Roche Diagnostics Corp.: 4 (https://510kreport.com/company/roche-diagnostics)
- Sysmex America, Inc.: 2 (https://510kreport.com/company/sysmex-america)
- Genzyme Corp.: 2 (https://510kreport.com/company/genzyme)

## Firms that cite its devices most
- Seppim S.A.S.: 7 (https://510kreport.com/company/seppim)
- Elitechgroup: 4 (https://510kreport.com/company/elitechgroup)
- Elitechgroup Vital Scientific BV: 2 (https://510kreport.com/company/elitechgroup-vital-scientific)
- Horiba, Ltd.: 1 (https://510kreport.com/company/horiba)
- Elitechgroup Seppim S.A.S.: 1 (https://510kreport.com/company/elitechgroup-seppim)

## Its most-cited devices
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) (2005), cited by 9
- K070249: Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/H (2007), cited by 6
- K060854: Abx Pentra 400:  Lipoproteins (2006), cited by 3
- K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP (2007), cited by 2
- K060325: Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P (2006), cited by 2
- K060318: Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer (2006), cited by 2

## Recent decisions
- K260781: Yumizen H550 (Sep 14, 2026)
- K232946: Yumizen H2500 (May 21, 2024)
- K193649: Yumizen C1200 Creatinine PAP (May 10, 2021)
- K193525: Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (Jun 26, 2020)
- K192028: Yumizen C1200 CRP (Jun 25, 2020)
- K191562: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (Mar 6, 2020)
- K191993: Yumizen C1200 CRP (Oct 3, 2019)
- K191245: Yumizen C1200 ALP, Yumizen C1200 Albumin (Aug 30, 2019)

Source page: https://510kreport.com/company/horiba-abx